Reaction mass of N,N-ethanediylbis- Hexadecanamide, N-[2-[(1-oxohexadecyl)amino]ethyl]-Octadecanamide, Hexadecanoic acid, 12-hydroxystearic acid, reaction products with ethylenediamine, N,N-ethanediylbis-Octadecanamide and Octadecanoic acid, 12-hydroxystearic acid, reaction products with ethylenediamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of N,N-ethanediylbis- Hexadecanamide, N-​[2-​[(1-​oxohexadecyl)​amino]​ethyl]​-Octadecanamide, Hexadecanoic acid, 12-​hydroxystearic acid, reaction products with ethylenediamine, N,N-ethanediylbis-Octadecanamide and Octadecanoic acid, 12-​hydroxystearic acid, reaction products with ethylenediamine

EC Number:

906-763-4

Molecular formula:

not applicable, mixture of substances

IUPAC Name:

Reaction mass of N,N-ethanediylbis- Hexadecanamide, N-​[2-​[(1-​oxohexadecyl)​amino]​ethyl]​-Octadecanamide, Hexadecanoic acid, 12-​hydroxystearic acid, reaction products with ethylenediamine, N,N-ethanediylbis-Octadecanamide and Octadecanoic acid, 12-​hydroxystearic acid, reaction products with ethylenediamine

Test material form:

other: Nearly white solid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan Netherlands BV
- Age at study initiation: 14-15 weeks (male), 14-15 weeks (females)
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks (RCC Ltd, Füllinsdorf) and haysticks 4642 (batch no. 77/05, Provimi Kliba AG) were provided for gnawing
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 8/06) provided by Provimi Kliba AG, CH-4303 Kaiseraugst
- Water (e.g. ad libitum):Community tap water from Füllinsdorf, ad libitum.
- Acclimation period: 01-JUN-2006 to 06-JUN-2006

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 01.06. To: 19.06.2006

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.1 g (per animal) of the test item reduced into a fine powder was weighed and applied undiluted as delivered by the Sponsor.

Duration of treatment / exposure:

TREATMENT:
The eyes of the animals were examined one day prior to test item administration. Animals with overt signs of ocular injury or irritation which may have interfered with the interpretation of the results were not used in the test.
On the day of treatment, 0.1 g of the test item was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of test item. The right eye remained untreated and served as the reference control. The treated eyes were not rinsed after instillation.

Observation period (in vivo):

The eyes of each animal were examined approximately after 1, 24, 48 and 72 hours as well as 7 and 10 days after administration. Eye examinations were made with a Varta Cliptrix diagnostic-lamp (Roth AG, CH-4153 Reinach/Switzerland).

Number of animals or in vitro replicates:

Number of animals per test: 3 (Animals of both sexes were used)
Age at treatment: 14-15 weeks (male); Male No. 58;
14-15 weeks (females); Females No. 59 and 60

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

not fully reversible within: 10 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

IRRITATION:
The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.00, 1.00 and 1.00 for reddening and 0.00 for chemosis for all three animals, respectively.
No abnormal findings were observed in the cornea of iris of any animal at any of the measurement intervals.
Slight to moderate reddening of the conjunctivae was noted in all animals at the 1-hour reading and persisted in two animals until the 48-hour reading. Slight to moderate reddening of the sclerae was present in all animals at the 1-hour reading and persisted in two animals until the 48-hour reading. No abnormal findings were observed in the treated eye of any animal 10 days after treatment.

COLORATION:
White remnants of the test item were observed in the eye or conjunctival sac of two animals one hour after treatment.

CORROSION:
No corrosion of the cornea was observed at any of the reading times.

BODY WEIGHTS:
The body weights of all rabbits were considered to be within the normal range of variability.

Other effects:

VIABILITY/MORTALITY AND CLINICAL SIGNS:
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:

other: not irritating to the eye

Conclusions:

Based upon the referred classification (Commission Directive 2001/59/EC of August 06, 2001), the substance is considered to be "not irritating" to the rabbit eye.

Executive summary:

The primary eye irritation potential of the substance was investigated according to OECD test guideline no. 405. The test item was applied by instillation of 0.1 g into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed 1, 24, 48 and 72 hours, as well as 7 and 10 days after test item instillation.

The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for the conjunctivae were 0.00, 1.00 and 1.00 for reddening and 0.00 for chemosis for all three animals, respectively.

The instillation of the test item into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, chemosis and discharge. These effects were reversible and were no longer evident 10 days after treatment. No abnormal findings were observed in the cornea or iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. White remnants of the test item and a slight ocular discharge were observed in the eye or conjunctival sac of two animals one hour after treatment. No clinical signs were observed.

Thus, the test item did not induce significant or irreversible damage to the rabbit eye. Based upon the referred classification criteria (Commission Directive 2001/59/EC of August 06, 2001), the substance is considered to be "not irritating" to the rabbit eye.